N/A
N=12,238
Asthma in Families Facing Out-of-pocket Requirements With Deductibles
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03175536 ↗Enrolled (actual)
12,238
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Change in Percentage of Days Covered for Inhaled Corticosteroids — 51.5; 44.7; 37.0; 29.1 percentage of days — p=0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- HDHP with PDL (Other)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Harvard Pilgrim Health Care
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Days Covered for Inhaled Corticosteroids |
51.5; 44.7; 37.0; 29.1 | 0.05 |
| PRIMARY Change in Percentage of Days Covered for Leukotriene Inhibitors |
70.3; 72.7; 58.4; 59.1 | 0.05 |
| PRIMARY Change From Baseline in Percentage of Days Covered for Inhaled Corticosteroid-long-acting Beta Agonist Medications |
55.9; 58.6; 44.3; 40.1 | 0.05 |
| PRIMARY Asthma-related Emergency Department (ED) Visits |
2.29; 2.48; 2.10; 2.10 | 0.05 |
| PRIMARY Out-of-pocket Costs |
130; 122; 85; 112 | 0.05 |
Summary
Asthma is one of the most common chronic diseases in the U.S. Despite guidelines, adherence to recommended controller medications is low. Cost is an important barrier to adherence. Employers are increasingly adopting high-deductible health plans (HDHPs) which require deductibles of > $1,000 per individual/$2,000 per family each year. In HDHPs with Health Savings Accounts (HSAs), most medications and non-preventive care must be paid out-of-pocket (OOP) until the deductible is reached. The lower premiums of HSA-HDHPs are appealing, but the high level of OOP costs can lead patients to forgo needed care. HSA-HDHPs can exempt preventive care from the deductible, and employers can add Preventive Drug Lists (PDLs) which exempt certain chronic medications from the deductible (including asthma medications), making them free. PDLs have the potential to improve controller medication use, which could prevent negative health outcomes and reduce cost-related trade-offs for families.
The goal of this research is to evaluate the impact of these two developments in the health insurance market -- HSA-HDHPs and PDLs -- on medication use and clinical outcomes for adults and children with asthma. To do this, tteh investigators will first conduct in-depth interviews with patients with asthma and parents of children with asthma who have HDHPs and traditional plans. Interviews will collect patient-reported data on how patients and their families navigate their insurance plan and make health care decisions when faced with OOP costs. Findings from the interviews will inform analyses of data from a large national health plan from 2004-2017. Investigators will select adults and children with asthma whose employer switched them from traditional plans or HSA-HDHPs without PDLs to HSA-HDHPs with or without a PDL. Analyses will examine changes in asthma medication use, emergency department (ED) visits, hospitalizations, and OOP costs before and after changing plans compared to similar patients who did not switch to a HSA-HDHP. The study aims to: 1) understand health care decision making and experiences of families with asthma with HDHPs; 2) examine the impact of HSA-HDHPs with and without PDLs on use of asthma medications and asthma-related ED visits and hospitalizations; 3) examine the extent to which the response to HSA-HDHPs and PDLs is affected by the presence of other family members with asthma or other chronic conditions; 4) examine the impact of HSA-HDHPs with and without PDLs on OOP costs for families.
Eligibility Criteria
Inclusion Criteria
- adult or child with asthma, defined as having one outpatient claim, one emergency department claim, or one inpatient claim with an ICD-9/10 diagnosis code for asthma in the baseline period
- has employer-sponsored insurance from an employer who offers only one plan
- at least 24 months of continuous enrollment with pharmacy benefits between 2004 - 2017
Exclusion Criteria
- other co-morbid pulmonary conditions identified in claims data (cystic fibrosis, immunodeficiency, bronchiectasis, congestive heart failure, pulmonary hypertension, or pulmonary embolism)
- enrolled through an employer who offers a choice of health insurance plans
Data sourced from ClinicalTrials.gov (NCT03175536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.